Armstrong Discusses Biosimilars Provision in Health Reform LawAIS' Health Reform Week June 29, 2010
Mark Armstrong, a Member of the Firm in the Health Care and Life Sciences practice in the Houston office, was featured in an article about biosimilars provision in the health reform law.
According to the article, the health reform law has created an approval pathway, effective immediately, for biosimilar drugs. However, the article stated that the impact of the law hinges on FDA guidelines, which has yet to be released. In the meantime, so many questions remain about the specifics of the application process.
A biosimilar, is "highly similar to the reference product notwithstanding minor differences in clinically inactive components," said Armstrong. Such drugs have "no clinically meaningful difference?...in terms of safety, purity and potency of the product." He continued to state that it is not a true generic, because it is not an exact replica of the innovator biologic.
According to Armstrong, over the next 10 years, proponents projected that the U.S. will save about $71 billion as a result of the biosimilar provision.